Syros Gets FDA Fast-Track Designation for Tamibarotene

By Colin Kellaher

Syros Pharmaceuticals has won U.S. Food and Drug Administration fast-track designation for its tamibarotene drug candidate in certain patients with acute myeloid leukemia.

The Cambridge, Mass., company on Tuesday said the designation covers tamibarotene in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia with RARA gene overexpression in adults who are over the age of 75 or who have comorbidities that preclude the use of intensive induction chemotherapy.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Syros is currently conducting a Phase 2 study of tamibarotene in combination with venetoclax and azacitidine in newly diagnosed, unfit AML patients with RARA overexpression.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

04-09-24 0734ET